Healthcare analytics solutions with advanced clinical decision support features may be classified as Software as a Medical Device (SaMD). For instance, this applies to software that enables remote control over wearable medical devices (e.g., an infusion pump or an implantable neuromuscular stimulator), provides AI-powered interpretation of medical images and test results, or sends alerts on patients’ states for potential clinical intervention. Since such software can directly affect patients and significantly influence treatment-related decisions, it must comply with IEC 62304:2006/Amd 1:2015 and ISO 13485 standards and requires FDA approval. To make sure our customers have flexibility in choosing their healthcare analytics features, ScienceSoft invests heavily in our expertise with the above regulations. We are ready to appoint relevant compliance experts to guarantee the future software adheres to all the requirements no matter how strict they are.